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Senior Study Manager (FSP)
Parexel International Corporation
United Kingdom, Remote
Position Purpose:
The Senior Study Manager (SSM) has responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
The SSM leads and manages the tactical execution of one or more clinical studies from study startup through database release and inspection readiness to ensure timely delivery of quality study data.
The SSM provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution
The SSM may also input to and support compilation of sections to Clinical Study Reports
The SSM will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans
The SSM is a core member of the Study Team and will represent the CRO on matters of study execution
The SSM works with functional lines and directly with CRO line functions to resolve or triage site level issues
The SSM will drive decision making and work closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy
For studies where more than one SSM is assigned, may be required to act as ‘lead’ SSM and will coordinate activities of the other SSMs assigned
Primary Duties:
Operational Study Management for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies.
Accountable for the development of realistic detailed study start-up and monitoring plans
Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
Leads study risk planning process in context of site and subject
Coordinates study/protocol training and Investigator Meetings
Develops and provides key inputs to Clinical Trial Budget (e.g., per subject costs)
Accountable for the delivery of the study against approved plans
Leads inspection readiness activities related to study management and site readiness
May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain (SC) Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)
Study Management Oversight
Approves the Study Start-up, Study Monitoring and protocol Recruitment Plans
Approves and oversees drug supply management - manages flow of drug supply to the sites and set-up Interactive Voice Randomization System (IVRS) with Supply Chain Lead
Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
May support study level submission readiness
Study Team Interface
Leads and oversees all elements of study start-up and monitoring functions both internally and at the CROs to ensure delivery and compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards
Interfaces directly with CRO to determine Feasibility/Study Start-up, Monitoring/Management, and Site Contracting Groups
o Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery
Shares and escalates plan deviations to CSTL (and study team)
Provides ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting for financial planning
Provides operational input into protocol design
Subject Matter Expertise
Serves as the technical expert for study management systems and processes
Champions the implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals
Responsible for the technical oversight of the CRO to include, but not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics
Partners with CRO Managers to proactively identify and resolve study operations staff performance issues
For project-specific audits and inspections, can serve as a resource to the study team to facilitate the audit/inspection
General
Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training
Adheres to EP and Client SOPs and processes
Skills and Education:
BS/Nurse – minimum of 5 years relevant experience
MS/PhD – minimum of 3 years relevant experience
Extensive global clinical trial/study management experience
Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
Demonstrated study management/leadership experience
Demonstrated oversight of CROs
Demonstrated experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend
Understands how to work with vendors to accomplish tasks
Ability to interpret study level data and translate and identify risks
Ability to proactively identify and mitigate risks around site level in study execution
Understands feasibility of protocol implementation
Country level cultural awareness and strong interpersonal skills
Keen problem-solving skills
Excellent communication skills, both written and verbal
Must be fluent in English
Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)
Job posted: 2023-10-04